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Electrical Nerve Block for Amputation Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02221934
Recruitment Status : Recruiting
First Posted : August 21, 2014
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Neuros Medical, Inc.

Tracking Information
First Submitted Date  ICMJE August 15, 2014
First Posted Date  ICMJE August 21, 2014
Last Update Posted Date June 18, 2020
Actual Study Start Date  ICMJE October 9, 2014
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2018)
  • Primary Effectiveness Endpoint: Reduction of Pain Level by 50% from Baseline [ Time Frame: 3 months post implant ]
    Demonstration of 50% reduction in a Numerical Rating Scale (NRS) pain score from pre-treatment to post-treatment for more than 50% of all pain episodes. Study success will be determined by a superiority test on the difference between responder rates in the Test group (those receiving the treatment) and Control group (those who do not receive treatment).
  • Primary Safety Endpoint: Incidence of Reported and Adjudicated Serious Adverse Events [ Time Frame: From consent through 3 months post implant ]
    Incidence of all serious adverse events including serious adverse device events and unanticipated adverse device events.
Original Primary Outcome Measures  ICMJE
 (submitted: August 19, 2014)
  • Pain reduction after each treatment session as measured by Numerical Rating Scale [ Time Frame: 3 months post implant ]
  • Incidence of all serious adverse events [ Time Frame: 3 months post implant ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2017)
  • Secondary Effectiveness: Pain Relief after 2 hours [ Time Frame: 12 months post implant ]
    Average percent change of pain intensity from before treatment, 30 minutes post treatment, and 2 hours post treatment
  • Secondary Effectiveness: Pain Days per Week [ Time Frame: 12 months post implant ]
    Average number of pain days compared at Month 3, Month 6 and Month 12 to Baseline.
  • Secondary Effectiveness: Pain Medication Use [ Time Frame: 12 months post implant ]
    Average morphine equivalent dose per day over two weeks compared at Month 3, Month 6 and Month 12 to Baseline.
  • Secondary Effectiveness: Pain Interference to Activities of Daily Living (ADL [ Time Frame: 12 months post implant ]
    Brief Pain Inventory summary score compared at Month 3, Month 6 and Month 12 to Baseline.
  • Secondary Effectiveness: Health-related quality of life (HR-QOL) [ Time Frame: 12 months post implant ]
    EQ-5D summary index, SF-12 physical component and mental component summary compared at Month 3, Month 6 and Month 12 to Baseline.
  • Secondary Effectiveness: Patient Global Impression of Change (PGIC) [ Time Frame: 12 months post implant ]
    Comparison of Patient Global Impression of Change across the Month 3, Month 6 and Month 12 office visits
  • Secondary Safety [ Time Frame: 12 months post implant ]
    Incidence of all Non-Serious Adverse Events, including Non-Serious Adverse Events, Non-Serious Adverse Device Events, and Unanticipated (Non-Serious) Adverse Device Events from the time of consent through 12 months post implant.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2014)
  • Pain Medication Use [ Time Frame: 12 months post implant ]
  • Pain interference to Activities of Daily Living (ADL) [ Time Frame: 12 months post implant ]
  • Health-related quality of life (HR-QOL) [ Time Frame: 12 months post implant ]
Current Other Pre-specified Outcome Measures
 (submitted: September 20, 2017)
Exploratory Efficacy: Prosthetic Use [ Time Frame: 12 months post implant ]
Average hours of prosthetic use per week averaged across two weeks compared at Month 3, Month 6 and Month 12 to Baseline.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Electrical Nerve Block for Amputation Pain
Official Title  ICMJE High-Frequency Nerve Block for Post-Amputation Pain: A Pivotal Study
Brief Summary The purpose of the clinical trial is to learn whether electrical nerve block via the Altius System is a safe and effective treatment for patients with post-amputation pain.
Detailed Description The Altius System is an implanted device designed to electrically block nerve signals and alleviate pain. Use of this device may be associated with providing an effective, mechanism-based yet non-destructive, treatment for managing intractable limb pain in amputees. In a given patient, the Altius System will be deemed effective if treatment results in 50% reduction of pain score for more than 50% of all pain episodes.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Post-Amputation Pain
  • Phantom Limb Pain
  • Residual Limb Pain
  • Stump Pain
Intervention  ICMJE Device: Altius
Electrical signal
Study Arms  ICMJE
  • Experimental: Signal more likely to block nerve
    Electrical signal delivered to nerve by Altius, a device designed for high-frequency nerve block
    Intervention: Device: Altius
  • Active Comparator: Signal less likely to block nerve
    Electrical signal delivered to nerve by Altius, a device designed for high-frequency nerve block
    Intervention: Device: Altius
Publications * Soin A, Shah NS, Fang ZP. High-frequency electrical nerve block for postamputation pain: a pilot study. Neuromodulation. 2015 Apr;18(3):197-205; discussion 205-6. doi: 10.1111/ner.12266. Epub 2015 Feb 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 22, 2018)
180
Original Estimated Enrollment  ICMJE
 (submitted: August 19, 2014)
130
Estimated Study Completion Date  ICMJE September 2026
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Age ≥ 21 years old
  • Unilateral amputated leg ≥ 12 months
  • Chronic post amputation pain ≥ 6 months
  • Pain episodes typically lasting ≥ 60 minutes
  • Stable drug regimen ≥ 6 weeks
  • No changes to medications or prosthesis for 3-month primary study period

Key Exclusion Criteria:

  • Implanted with an active implantable medical device (i.e. pacemaker)
  • Confounding source of pain that interferes with reporting of limb pain
  • Uncontrolled diabetes
  • Spasticity preventing full range of motion of involved side
  • Extremely short stump; sits on end
  • Untreated psychological condition (i.e. borderline personality)
  • Condition requiring MRI studies or diathermy after device implant
  • Life expectancy of less than 24 months
  • Progressive neurological disease (i.e. multiple sclerosis)
  • Subjects with active local or systemic infection or immunocompromised
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David Veino 440-951-2565 ext 124 dveino@neurosmedical.com
Contact: Gita Ghadimi 440-951-2565 ext 180 gghadimi@neurosmedical.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02221934
Other Study ID Numbers  ICMJE 003-0001
QUEST Trial ( Other Identifier: Neuros Medical )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Neuros Medical, Inc.
Study Sponsor  ICMJE Neuros Medical, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leonardo Kapural, MD, PhD Center for Clinical Research, Winston-Salem NC
PRS Account Neuros Medical, Inc.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP